AdvaMed Asks CMS to Widen RAPID Medicare Pathway for Breakthrough Devices

AdvaMed, the medical technology industry's main trade group, has asked the Centers for Medicare & Medicaid Services to widen eligibility for its proposed RAPID coverage pathway for breakthrough devices and to let diagnostics take part, in comments filed days before the public comment period closes on October 13.

The group set out its recommendations in an October 8 statement. "Medicare beneficiaries shouldn't have to wait for FDA-authorized breakthrough technologies," AdvaMed president and CEO Scott Whitaker said in the statement, adding: "CMS has taken an important step toward that goal with RAPID."

What CMS has proposed

RAPID, short for Regulatory Alignment for Predictable and Immediate Device, was published as a notice with comment period in the Federal Register on August 11. Under it, CMS would post a proposed national coverage determination on the same day the FDA authorizes an eligible device, provided the agencies find enough clinical evidence that the device meets health outcomes agreed for Medicare beneficiaries. CMS said its goal is to finalize coverage "as soon as 60 days later for Class II devices and 90 days later for Class III devices."

The notice limits eligibility to presumptive Class II breakthrough-designated devices that take part in the FDA's Total Product Life Cycle Advisory Program (TAP) and plan to seek De Novo classification, and to Class III breakthrough-designated devices planning a premarket approval application, whether or not they are in TAP. Devices must still be at the investigational device exemption (IDE) presubmission stage, with a planned IDE study that enrolls Medicare beneficiaries. Devices already authorized or already under an IDE study are not appropriate candidates, the notice says.

The notice also excludes in vitro diagnostics. CMS wrote that coverage for most breakthrough-designated diagnostic tests "should continue to be determined by the MACs," the regional Medicare administrative contractors, and that "IVD products will not be accepted into the RAPID coverage pathway." Participation would be voluntary.

What industry wants changed

According to AdvaMed's statement, the group recommended that CMS and FDA ensure RAPID is "adequately resourced, transparent, and aligned" with the FDA's risk-based framework; broaden eligibility for breakthrough-designated devices; avoid unnecessary procedural barriers; allow appropriate participation by diagnostics; set firm timelines for national coverage determinations; coordinate coverage, coding and payment; and create transition protections for technologies already developed or planned under earlier CMS coverage pathways.

As MedTech Dive reported on October 9, CMS estimates that about 40 devices would currently qualify for the pathway, with about 20 more that could qualify later. The outlet noted the proposal is narrower than the automatic four-year coverage proposed during the first Trump administration, which was later scrapped.

Next steps

The Federal Register notice, docketed as CMS-3487-NC, says comments must be received by October 13, 2026, to be assured consideration. MedTech Dive reported that CMS will respond to comments in a subsequent final notice, and that the pathway would take effect when that notice is published.

RAPID would sit alongside CMS's existing Transitional Coverage for Emerging Technologies pathway, finalized in 2024, which the RAPID notice describes as voluntary and built on current national coverage and coverage-with-evidence-development processes.